Comparing two treatments for severe urinary symptoms in men with prostate enlargement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The TUMT-PAE-1 trial is a randomized clinical trial designed to evaluate the effectiveness of transurethral microwave thermotherapy (TUMT) versus prostatic artery embolization (PAE) in alleviating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). The study will assess urinary symptoms six months post-procedure using the International Prostate Symptom Score (IPSS) and will also analyze patient-reported outcomes related to satisfaction and quality of life. Both treatments are less invasive alternatives to the traditional surgical option of transurethral resection of the prostate (TURP), which may not be suitable for all patients. The trial aims to determine if TUMT is non-inferior to PAE in managing these symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to understand and the willingness to sign an informed consent.
* Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment or not patient preference.
* Severe urinary symptoms on IPSS (IPSS score ≥ 20).
* Bladder outlet obstruction (BOO) is defined by Qmax ≤ 15ml/sec, based on uroflowmetry.
* Prostate volume at minimum 50 ml measured by TRUS or MR.
* Men with prostate cancer in Active Surveillance or Watchful Waiting who have LUTS due to a large BPH component are allowed.
* Indwelling catheter or intermittent catheter is allowed. In this case baseline IPSS is 35 points.

Exclusion Criteria:

* Active bladder cancer (patients with pTa low-grade tumors are allowed).
* Previous pelvic radiation for cancer treatment.
* Bladder stones (inclusion is allowed after removal).
* Current urethral strictures or bladder neck contracture.
* Neurogenic LUTS.
* Symptomatic urinary tract infection at the time of intervention.
* Documented bacterial prostatitis in the last year.
* Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist).
* Allergy to iodinated contrast media.
* Renal failure defined as estimated glomerular filtration rate (eGFR) \< 35ml/min.
* High bleeding risk (spontaneous international normalized ratio (INR) \> 1.6).
* Contraindication to conscious sedation (if requested by the patient).
* Prostate median lobe defined by treating physician.
* Urethral colliculus to bladder neck length \<35mm.

Where it's running

• Urological Research Unit, Rigshospitalet
  Copenhagen, Copenhagen N, Denmark Recruiting
• Department of Urology, Herlev-Gentofte Hospital
  Gentofte Municipality, Hellerup, Denmark Recruiting
• Zealand University Hospital
  Roskilde, Denmark Recruiting

Study contacts

• Study coordinator: Anna Kristensen-Alvarez, MD
• Email: anna.kristensen-alvarez@regionh.dk
• Phone: +4535456152

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.